Senior Compliance Engineer
Company: Abbott Laboratories
Location: Los Angeles
Posted on: April 10, 2021
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Job Description:
Abbott is a global healthcare leader that helps people live more
fully at all stages of life. Our portfolio of life-changing
technologies spans the spectrum of healthcare, with leading
businesses and products in diagnostics, medical devices,
nutritionals, and branded generic medicines. Our 109,000 colleagues
serve people in more than 160 countries.About AbbottFor years,
Abbott's medical device businesses have offered technologies that
are faster, more effective, and less invasive. Whether it's glucose
monitoring systems, innovative therapies for treating heart
disease, or products that help people with chronic pain or movement
disorders, our medical device technologies are designed to help
people live their lives better and healthier. Every day, our
technologies help more than 10,000 people have healthier hearts,
improve quality of life for thousands of people living with chronic
pain and movement disorders, and liberate more than 500,000 people
with diabetes from routine ?ngersticks.A healthy heart is essential
to good health. That's why we're committed to advancing treatments
for people with cardiovascular disease. As a global leader in
Cardiac Rhythm Technologies, our breakthrough medical technologies
help restore people's health so they can get back to living their
best lives, faster. We focus on innovative technologies that can
improve the way doctors treat people with heart arrhythmias, or
irregular heartbeats.Our location in Sylmar, CA, currently has an
opportunity for a Senior Compliance Engineer.WHAT YOU'LL DOJob
DescriptionThe Senior Compliance Engineer provides direction and
leadership from within the Quality Systems group to R&D,
Quality, Operations and Regulatory Affairs, to ensure the Quality
System works optimally and complies with global external
regulations and standards.The position maintains and improves
Cardiac Rhythm Management (CRM) Quality System and supports the
execution of key Quality System processes such as audits, CAPA,
training, change management and management review.Main
ResponsibilitiesThe Compliance Engineer ensures that the division
main quality systems are properly supported to ensure regulatory
compliance. This position also ensures optimization of the QS to
make more efficient the product realization. Lead planning and
execution of internal and external audits.Assess and continually
improve the areas of training, change management and CAPA
processes.Support the management review process to ensure
management responsibility commitments are met.Assess the compliance
of CRM processes and product portfolio against applicable
regulations and standards. Facilitate CAPA process by providing
subject matter expertise, evaluating adequacy of investigations and
actions taken against established criteria, and assisting in the
completion of CAPA projects in order to ensure process compliance
and record quality.Monitors compliance of company policies and
procedures with regulatory requirements (e.g. compliance with FDA,
ISO 13485, EUMDR, TGA, Anvisa, PMDA, NMPA, and emerging market
regulations and standards etc).Monitor external sources of
information to identify applicable regulations and standards and
determine necessity of company product conformity.Support internal
and external audits as subject matter expert for sustaining state
of the art conformity during the product lifecycle.The position
serves a strategic purpose for Abbott and must achieve a balance of
involvement and objectivity,Demonstrate appropriate risk-based
decision making, and prioritize key activities to maintain product
conformity and GMP/QMS compliance.The position also provides an
active role within the Corporation as Divisional experts in
external regulatory requirements and applicable standards.Support
all Divisional initiatives as identified by divisional management
and in support of Quality Management Systems (QMS), Environmental
Management Systems (EMS), and other regulatory requirementsAs
appropriate, participates in or leads teams in supporting quality
disciplines, decisions, and practices (e.g., represent the Quality
System function as a Team Member)EDUCATION/EXPERIENCE YOU'LL
BRING:Bachelors Degree and 5+ years of related work experience with
a strong understanding of specified functional area, an equivalent
combination of education and work experience* Medical
Devices/Pharma experience is required* CAPA experience is required*
Experience working with standards/regulationsWide application of
technical principles, practices, and procedures. Strong
understanding of business unit function and cross group
dependencies/ relationships. Will perform this job in a quality
system environment. Failure to adequately perform tasks can result
in noncompliance with governmental regulations.Works on problems of
diverse scope where analysis of data requires evaluation of
identifiable factors. Exercises judgment within generally defined
practices and policies in selecting methods and techniques for
obtaining solutions. Has a sound knowledge of various technical
alternatives and their impact.WHAT WE OFFER * At Abbott, you can
have a good job that can grow into a great career. We offer:*
Training and career development, with onboarding programs for new
employees and tuition assistance* Financial security through
competitive compensation, incentives and retirement plans* Health
care and well-being programs including medical, dental, vision,
wellness and occupational health programs* Paid time off* 401(k)
retirement savings with a generous company match* The stability of
a company with a record of strong financial performance and history
of being actively involved in local communitiesLearn more about our
benefits that add real value to your life to help you live fully:
www.abbottbenefits.comFollow your career aspirations to Abbott for
diverse opportunities with a company that provides the growth and
strength to build your future. Abbott is an Equal Opportunity
Employer, committed to employee diversity.Connect with us at
www.abbott.com, on Facebook at www.facebook.com/Abbott and on
Twitter @AbbottNews and @AbbottGlobal.
Keywords: Abbott Laboratories, Los Angeles , Senior Compliance Engineer, Engineering , Los Angeles, California
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